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Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121055
First Posted: May 12, 2010
Last Update Posted: May 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  Purpose
Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during the procedure. The investigators want to evaluate whether an additional Lorazepam premedication would improve patient satisfaction for FB.

Condition Intervention Phase
Patient Satisfaction for Bronchoscopy Drug: Lorazepam Drug: Control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: within 24 hr of bronchoscopy ]

Secondary Outcome Measures:
  • relationship between patient satisfaction and sleep quality, anxiety level [ Time Frame: 24hr before and after bronchoscopy ]

Estimated Enrollment: 372
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
Drug: Control
Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB
Experimental: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
Drug: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

Detailed Description:
The enrolled patients are randomized to either the control or Lorazepam groups according to a random sample chart of numbers. The patients complete questionnaires about baseline anxiety level and satisfaction for FB within 24 hours after the FB.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (aged 18 years or older) admitted to the Respiratory Department

Exclusion Criteria:

  • outpatient procedures
  • therapeutic bronchoscopy
  • expected operation or discharge within 24 hours after the FB
  • sedative premedication
  • endotracheal intubation with mechanical ventilation
  • inability to speak Korean
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121055


Contacts
Contact: Seok-Chul Yang, MD, PhD +82-2-2072-0354 scyang@snu.ac.kr
Contact: Jong Sun Park, MD jspark.im@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seok-Chul Yang, MD       scyang@snu.ac.kr   
Contact: Jong Sun Park, MD       jspark.im@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Seok-Chul Yang, MD Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
  More Information

Responsible Party: Seok-Chul Yang, MD, PhD, FCCP, Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
ClinicalTrials.gov Identifier: NCT01121055     History of Changes
Other Study ID Numbers: Lorazepam in FB
First Submitted: May 9, 2010
First Posted: May 12, 2010
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by Seoul National University Hospital:
Fiberoptic Bronchoscopy
Patient
Satisfaction
Lorazepam

Additional relevant MeSH terms:
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action